Recognized standard
F3127-16
FDA recognition 8-442 · ASTM · Materials
Key facts
| Recognition number | 8-442 |
|---|---|
| Designation | F3127-16 |
| Title | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: